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Universal Meditech Inc. issued the recall for Skippack Medical Lab antigen tests because they were distributed without appropriate clearance or approval by the US Food and Drug Administration (FDA).
The kits were made from October 2021 to December 2021 and distributed in January 2022.
The following styles/models have been recalled:
- Name of Product: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit
- UDI: None
- Model: Cassette
Products were distributed with “Skippack Medical Lab” branded Instructions for use leaflet in three different packaging boxes identified below:
- Purple and white box under “Skippack Medical Lab” brand:
- Green and white box under “DiagnosUS” brand
- White box without brand name
Consumers with questions may contact the legal attorney of the company via telephone at 702-871-9888 between noon and 8 p.m. Eastern Time.
Consumers may also contact the legal attorney of the company via e-mail at m@linlawgroup.com.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax:
Complete and submit the report online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
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